New device for treating severe respiratory failure
A Novel ECCO2R Device as a Lung Protective Measure in Hypercapnic Respiratory Failure: a Prospective Multicenter Trial
This study is testing a new device called Prismalung+ to see if it can help people with severe breathing problems breathe better and avoid needing a breathing tube.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Saint Gallen) |
| Trial ID | NCT05316532 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of the Prismalung+ membrane in patients with hypercapnic respiratory failure. It aims to demonstrate a reduction in ventilatory parameters and pulmonary energy load, or to maintain spontaneous breathing without the need for intubation. The study will involve mechanically ventilated patients and those who are spontaneously breathing, conducted across multiple intensive care units in Switzerland. The primary objectives include assessing the device's impact on ventilation and survival rates.
Who should consider this trial
Good fit: Ideal candidates include mechanically ventilated patients with progressive respiratory failure or awake spontaneously breathing patients experiencing respiratory exhaustion.
Not a fit: Patients requiring v-v ECMO or those unable to remain un-sedated for mechanical ventilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the management of patients with severe respiratory failure, potentially reducing the need for invasive ventilation methods.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with respiratory failure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT\<4 mL/kg, Ppeak \<30 mbar, Driving Pressure ≤12 mbar) * OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa) * AND Informed Consent as documented by signature Exclusion Criteria: * Mechanical Ventilation group: Need for v-v ECMO * Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated * Thrombocytopenia (\<100G/l) * Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding) * Patients under 18 years of age * Women who are pregnant or breast feeding * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons
Where this trial is running
Saint Gallen
- Kantonsspital St. Gallen — Saint Gallen, Switzerland (Recruiting)
Study contacts
- Principal investigator: Matthias P Matthias, PD Dr. med. — University of Zurich
- Study coordinator: Stefanie Keiser, Dr. Sc. nat.
- Email: stefanie.keiser@usz.ch
- Phone: +41797956912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.